MagnetisMM-4: Umbrella Study of Elranatamab (PF-06863135) in Combination With Anti-Cancer Treatments in Multiple Myeloma

A PHASE 1B/2, OPEN LABEL UMBRELLA STUDY OF ELRANATAMAB (PF-06863135), A B-CELL MATURATION ANTIGEN (BCMA) CD3 BISPECIFIC ANTIBODY, IN COMBINATION WITH OTHER ANTI-CANCER TREATMENTS IN PARTICIPANTS WITH MULTIPLE MYELOMA

The purpose of this study is to determine the Recommended Phase 2 Dose and clinical benefit of elranatamab in combination with other anti-cancer therapies in participants with multiple myeloma.

Inclusion Criteria:

• Relapsed/refractory multiple myeloma with at least 3 prior lines of therapy

• Refractory to at least one IMiD, one proteasome inhibitor, and one anti-CD38 antibody

• Measurable disease defined by at least one of the following:

  1. Serum M-protein >/= 0.5 g/dL by SPEP
  2. Urinary M-protein excretion >/= 200 mg/24 hours by UPEP
  3. Serum immunoglobulin FLC >/= 10 mg/dL (>/= 100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio

• ECOG performance status 0 -1

• Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade </= 1

Exclusion Criteria:

• Active plasma cell leukemia
• Amyloidosis
• Stem cell transplant with 12 weeks prior to enrollment, or active GVHD
• POEMS syndrome
• Any active uncontrolled bacterial, fungal, or viral infection
• Impaired cardiovascular function or clinically significant cardiovascular diseases within 6 months prior to enrollment
• Previous administration with an investigational drug within 30 days or 5 half-lives preceding the first dose of study treatment (whichever is longer)
• Sub-Study A Only: Previous treatment with BCMA bispecific antibody
• Sub-Study B Only: Previous treatment with BCMA directed therapy